Associate Director, External Site Quality Leader

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create a codependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The External Site Quality Leader (ESQL) is accountable for providing Quality Oversight over one or more External Entities that manufactures or tests cell banks, biologic drug intermediates, biologic drug substances, or biologic drug products or both on behalf of our Company's Manufacturing Division. Activities include the broadest possible involvement in every aspect of manufacturing and testing operations related to the quality and compliance of products produced.

• Accountable for oversight of an External Entity (EE) involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
• Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight | Components may include review of batch documentation and deviation investigations.
• Assist in managing the end-to-end processes of transfers including but not limited to: Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness and Quality System Oversight Implementation.
• Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews | Includes building effective quality systems at the EE and continuous improvement activities.
• Exhibits our company Leadership Behaviors and provides a leadership example for the team.
• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.
• Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.
• Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.

Education

• Bachelor's or master’s degree in a Science, Engineering, or related area of study with eight (8) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements

Experience and Skills

Required

• Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines.  Aseptic manufacturing experience.
• Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities
• Strong and principled interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
• Works independently, receives minimal guidance.
• Communicates in English both verbally and in writing

Desirable Experience:

• Direct experience with managing external partners (CMOs, Labs, etc.)
• Experience in batch disposition, deviation management, change control and participating in regulatory inspections.
• Qualified Person

As this role is a remote role in Ireland, Switzerland or Spain travel is required - 25%, occasionally on short notice. You must be based in one of these countries for your application to be considered.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.  

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.  

So, if you are ready to: 

Invent solutions to meet unmet healthcare needs, please apply today. 

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R278695